FDA
The new article highlights aspects related to the second stage of the application review process and also describes the approach to be applied when making changes to a tool after its qualification. Table of Contents The Food and Drug Administration (FDA or the...
FDA
The new article describes in detail the matters related to MR compatibility and also provides a brief overview of non-clinical testing and the way it should be conducted. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating...
FDA
The new article addresses aspects related to the initial proposal and the way it will be assessed by the authority during the acceptance review. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...
Europe
The new article highlights aspects related to changes to medical device registration and also describes in detail the public register of medical device manufacturers. Table of Contents The Medicines and Healthcare Products Regulatory Agency (MHRA), the UK regulating...
FDA
The new article highlights aspects related to pyrogenicity, (accelerated) aging, packaging, ensuring that the sterility of the device is duly maintained, as well as biocompatibility for all the components and patient-contacting materials. Table of Contents The Food...
FDA
The new article highlights aspects related to the MDDT program, its intended purpose, and its benefits. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance...
